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Monitoring Patients With Uncontrolled Epilepsy

Primary Purpose

Epilepsy, Seizures

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Epilepsy focused on measuring Anticonvulsants, Intensive Monitoring, Epilepsy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

History of uncontrolled seizures, at the present time, at least during 6 months of the past 3 years, and preferably a continuous pattern of seizures during the few months prior to admission. Seizure frequency, by history, must be sufficient to make video monitoring effective. Priority will be given to patients whose seizures occur once or more per day. Patients of any age may be accepted. Patients (and parents or guardians, if applicable) must express willingness to cooperate with the entire protocol, to be willing to undergo further diagnostic tests if needed, and to return for follow up evaluation at intervals as needed.

Sites / Locations

  • National Institute of Neurological Disorders and Stroke (NINDS)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00001149
Brief Title
Monitoring Patients With Uncontrolled Epilepsy
Official Title
Monitoring of Seizures, EEG and Serum Antiepileptic Drug Concentrations in Patients With Uncontrolled Epilepsy
Study Type
Observational

2. Study Status

Record Verification Date
January 2002
Overall Recruitment Status
Completed
Study Start Date
November 1975 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
This study is designed to evaluate patients with uncontrolled seizures. Seizures can be associated with and monitored by abnormal electrical activity in the brain. In this study researchers will use video-electroencephalography (EEG) to monitor patients with uncontrolled or suspected seizures. EEG works by measuring electrical activity in different areas of the brain. The video-EEG allows researchers to examine changes in the EEG along with the clinical features of seizures as they occur. In addition to monitoring electrical activity of the brain, researchers will take frequent antiepileptic drug blood levels. These measures will allow researchers to learn more about how each drug is absorbed and metabolized in the body. The information collected in the study will be used to place patients into other scientific studies testing new therapies for epilepsy.
Detailed Description
In this study we will use standard clinical studies, including simultaneous Video-EEG monitoring, to evaluate patients referred for uncontrolled or suspected seizures. The protocol will be used to screen patients for inclusion in other protocols, follow the natural history of seizure disorders, and train fellows in the evaluation and treatment of epilepsy. Both inpatients and outpatients will be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Seizures
Keywords
Anticonvulsants, Intensive Monitoring, Epilepsy

7. Study Design

Enrollment
900 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
History of uncontrolled seizures, at the present time, at least during 6 months of the past 3 years, and preferably a continuous pattern of seizures during the few months prior to admission. Seizure frequency, by history, must be sufficient to make video monitoring effective. Priority will be given to patients whose seizures occur once or more per day. Patients of any age may be accepted. Patients (and parents or guardians, if applicable) must express willingness to cooperate with the entire protocol, to be willing to undergo further diagnostic tests if needed, and to return for follow up evaluation at intervals as needed.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
6684245
Citation
Theodore WH, Porter RJ, Penry JK. Complex partial seizures: clinical characteristics and differential diagnosis. Neurology. 1983 Sep;33(9):1115-21. doi: 10.1212/wnl.33.9.11515.
Results Reference
background
PubMed Identifier
1182486
Citation
Penry JK, Porter RJ, Dreifuss RE. Simultaneous recording of absence seizures with video tape and electroencephalography. A study of 374 seizures in 48 patients. Brain. 1975 Sep;98(3):427-40. doi: 10.1093/brain/98.3.427.
Results Reference
background
PubMed Identifier
2106868
Citation
Altshuler LL, Devinsky O, Post RM, Theodore W. Depression, anxiety, and temporal lobe epilepsy. Laterality of focus and symptoms. Arch Neurol. 1990 Mar;47(3):284-8. doi: 10.1001/archneur.1990.00530030050016.
Results Reference
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Monitoring Patients With Uncontrolled Epilepsy

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